Smart Coil 400SMTSTD0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548014630), received between Jul 3, 2017 and Nov 25, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED RUBY COILS THROUGH THE MICROCATHETER AND IMPLANTED THEM INTO THE TARGET VESSEL. THE PHYSICIAN THEN DECIDED TO USE A 5MM X 10CM SMART COIL WITH THE SAME MICROCATHETER. IT WAS REPORTED THAT THE 5MM X 10CM SMART COIL WAS ADVANCED INTO THE MICROCATHETER SEVERAL TIMES BUT WAS UNABLE TO ADVANCE OUT. SUBSEQUENTLY, THE 5MM X 10CM SMART COIL BECAME BENT IN THE MICROCATHETER. THEREFORE, THE 5MM X 10CM SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370503 ↗
• MalfunctionOct 25, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE FRICTION LOCK OF THE SMART COIL WOULD NOT DISENGAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239058 ↗
• MalfunctionSep 6, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL SMART COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND THE HANDLE. THE PHYSICIAN THEN DEPLOYED A NEW SMART COIL AND ATTEMPTED TO DETACH THE COIL USING THE SAME HANDLE; HOWEVER, THE SMART COIL DID NOT DETACH EVEN THOUGH THE PET LOCK WAS SEPARATED. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL BY USING FORCEPS TO PULL BACK THE DETACHMENT WIRE. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL SMART COILS, THE SAME HANDLE AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6847125 ↗
• MalfunctionJul 3, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, AFTER ADVANCING A SMART COIL OUT OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN FELT FRICTION AND DECIDED TO WITHDRAW THE SMART COIL. HOWEVER, WHILE RETRACTING THE SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN FELT FRICTION AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL AND THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL SMART COILS AND A NEW MICROCATHETER WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684941 ↗